GUEST COLUMNISTS

• New ICH Q14 Guidance Applies QbD To Analytical Procedures

  ICH's new draft guidance (Q14) for Analytical Procedure Development describes an enhanced approach for method development, validation, and life cycle management employing elements of quality by design (QbD) and risk management tools. This article also explains the differences between this enhanced approach and the traditional approach.

• Key Considerations In Early-Stage Biopharma Financing

  After over two years of soaring IPO valuations and high stock prices, biotech had a reckoning in the back half of 2021. But while the industry is clearly facing headwinds, there’s significant cause for optimism for early-stage biotechs looking for funding, not the least of which is 2021’s high levels of venture capital fund formation.

• Make This Your New EU IDMP Implementation Strategy

  Just when the life sciences industry was as sure as it could be that EU Iteration 1 of ISO Identification of Medicinal Products (IDMP) implementation for centralized procedures in Europe was ready to go, the EMA announced a change of plan. Until further notice, the Digital Application Dataset Integration (DADI) user interface will be used to enable structured data submissions.

• Gene Therapy Competitive Dynamics: Winner Takes All?

  A one-time gene therapy treatment with the potential to cure patients could create a “winner takes all” dynamic, whereby second and later entrants for the same indication would have significantly smaller patient populations. The extent to this dynamic will occur will depend on how similar gene therapy treatments are considered by payers, KOLs, and physicians to be comparable.

• Key Considerations For Decarbonizing Your Biotech Facility

  Biopharmaceutical manufacturing processes do not directly utilize fossil fuels, but fossil fuels are used in the generation of raw materials, consumables, packaging, and in supplying energy to building systems and manufacturing equipment. This article looks at key facility decarbonizing considerations using a case study with quantification of estimated costs.

• How Will Advanced Computing Technologies Catapult Medtech Into The Future?

  There is an almost unlimited profit potential for medtech manufacturers to use advanced computing technologies such as AI, faster and smaller computing hardware, computing-driven robotics, AR/VR, and IoT to build devices that disrupt markets and improve people’s lives. This article delves into using data analytics (including AI), making more effective implantable devices, and collecting better patient data.

• Don’t Neglect This Drug Development Milestone: The Pre-IND Meeting

  The pre-IND meeting takes place when a sponsor presents their planned Phase 1 study design, including their proposed product development plan and regulatory strategy, to the FDA. Think of this as a necessary milestone for a quicker development timeline. This article shares best practices for preparing for the meeting as well as for the meeting itself.

• How To Evaluate & Manage Safety Risks In Biopharma

  Safety risks can be described and modelled as cause-and-effect relationships using system risk structures. This article structures risks beginning with a defined danger or threat so they can be effectively understood and then managed. Examples include wearing protective gloves (as a simple risk) and handling antibody-drug conjugates (as a complex risk).